Evaluation of Clinical Performance of 3D Printed Polyether Ether Ketone (PEEK) Inlays

NCT04532671 | Unknown DMC

• 1 other identifier: 88245
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

In patients using Inlay restorations will the use of 3D printed PEEK material and technique have superior clinical performance to milled PEEK one or to milled composite resin inlays, evaluation of restorations will be done at baseline, six months and 12 months using the modified US Public Health Service (USPHS) evaluation system

Conditions

Occlusal Caries

Outcome Measures

Primary Outcomes (4)

• Marginal integrity

  Visual inspection with explorer and mirror, Distance penetrated by the Explorer at the tooth restoration interface

  12 months

• marginal discoloration

  Visual inspection with a mirror at 18 inches, the degree of mismatch from the normal range of tooth shades and translucency Visual inspection to check the proximity of the shade from the natural tooth

  12 months

• secondary caries

  Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time

  12 months

• post operative sensitivity

  Asking the patient if there is any associated pain after adding the restoration

  12 months

Study Arms (3)

Poly ether ether ketone (PEEK)

OTHER

Poly ether ether keton (PEEK) is acknowledged as a high-performance polymer in engineering \& medical applications due to its favorable mechanical and chemical properties.

Other: Poly ether ether ketone (PEEK)

CADCAM poly ether ether ketone (PEEK)

OTHER

PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks.

Other: CADCAM Poly ether ether ketone (PEEK)

indirect resin composite

ACTIVE COMPARATOR

In CAD/CAM resin composite blocks, properties of flexibility and ease of use similar to that of resin composite are combined with durability and surface finish properties similar to that of ceramics

Other: indirect resin composite

Interventions

Poly ether ether ketone (PEEK) OTHER

PEEK has been used in dentistry so far in certain fields as for, removable and fixed dental prostheses, implants, and implant abutments as well as orthodontic devices, whereas in literature, it is mostly mentioned in relation to prosthetics. PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks. Producing dental restorations via Additive manufacturing is still hardly widespread

Poly ether ether ketone (PEEK)

CADCAM Poly ether ether ketone (PEEK) OTHER

Increased demand for long-lasting restoration's properties have led to many improvements in the production techniques of posterior restorations such as CAD/CAM systems. This technique simplifies the production of indirect restorations and make it possible to use advanced materials as PEEK

CADCAM poly ether ether ketone (PEEK)

indirect resin composite OTHER

CADCAM resin composite blocks using milling process

indirect resin composite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aging greater than or equal 18 years.
• Patients with a high level of oral hygiene.
• Each patient enrolled in the study had moderate to large size carious lesion or defective restoration to be replaced on a maxillary or mandibular permanent molar.
• Patients with good likelihood of recall availability.

You may not qualify if:

• Participants with general/systemic illness.
• Pregnant or lactating females.
• Concomitant participation in another research study.
• Inability to comply with study procedures.
• Heavy bruxism habits.
• Last experience with allergic reactions against any components of the used materials.
• Patients receiving orthodontic treatment.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

poly(phthalazine ether sulfone ketone)

Study Officials

• Donia M elshafey, master

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

donia M elshafey, master

CONTACT

1008820027; donia.mamdouh@dentistry.cu.edu.eg

dina E mohamed, Doctorate

CONTACT

1008007157; dina.ezz@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 31, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: expecting to have all the data during october 2022
• Access Criteria: IPD through contacting the main author doniamamdouh@dentistry.cu.edu.eg.com